Diabetes mellitus is an endocrine disorder, which affected 171 million people in the year 2000, and will affect 366 million by the year 2030. This disease is characterized by the defective regulation of blood glucose levels. These levels are regulated by a hormone, Insulin, which is secreted by the beta cells of the Islets of Langerhans in the pancreas. A defective secretion of insulin by the pancreas or resistance to the secreted insulin (insulin resistance) is the main cause of TYPE 2 diabetes mellitus. Defective insulin production is caused by the complex interaction of existing genetic factors with the environmental and life-style choices. In the current cosmopolitan society, life-style choices like obesity, inactivity, and indiscriminate consumption of “energy rich and nutrient lean” processed, frozen or ‘ready to eat’ foods coupled with prevailing conditions of obesity play a major role in increasing the occurrence of diabetes.
In a healthy body, glucose is effectively regulated by insulin via a closely monitored feedback pathway between the blood glucose levels and the pancreatic hormones. In a diabetic body, the blood glucose levels are on the rise since the defective pancreatic beta cells are not secreting the required amount of insulin. A mal regulation of glucose, which is the primary source of energy for metabolic processes and other cellular functions, causes various metabolic disorders, which are the long-term chronic conditions caused by the onset of diabetes. After the onset of Type 2 Diabetes mellitus, a number of chronic complications develop which affect multiple organs and are responsible for the morbidity and the mortality associated with the disease. Thus, the early diagnosis and immediate management of blood glucose levels is of great importance in the management of diabetes.
Diabetes affects the way the body absorbs and utilizes sugar blood sugar. With the same amount of nutrient intake, the body does not have the sufficient quantity of glucose to generate growth and energy. Additionally, there is also a greater level of catabolic activity causing muscle protein loss and negative nitrogen balance in diabetic patients when compared to individuals with normal blood sugar levels.
Hence, managing blood glucose levels should be coupled with an improvement in body composition in order to effectively manage this disease.
Apart from the growing diabetic population, another area of immediate concern is the alarming rate at which the “pre-diabetic” condition is spreading. In the pre-diabetic condition, the body cells gradually and progressively show an increased resistance to insulin. This resistance to an insulin stimulus leads to a situation of above normal blood glucose levels. Medically this state of elevated blood glucose levels is also referred to as Impaired Glucose Tolerance or Impaired Fasting Glucose (IGT/IFG), depending on which test was used to detect it. They exhibit one of these conditions.
Due to this state of elevated blood glucose levels, pre-diabetic individuals will progressively tend toward a diabetic state. Additionally they may already be experiencing the adverse and chronic health effects associated with a diabetic condition. Glucose circulates in the blood instead of being used by the cells for energy and hence blood glucose levels are elevated. For instance, people with pre-diabetes have a 1.5-fold risk of cardiovascular disease when compared to people with normal blood glucose.
Over 41 million adult Americans between the ages of 40 and 74 have pre-diabetes. Pre-diabetes is a precursor to type 2 diabetes. Obesity (body mass index, BMI>30), unhealthy diet and a sedentary lifestyle can lead to pre-diabetes. Obesity is a root cause of Insulin Resistance, which, in turn, is a key factor in the development of reversible Pre-Diabetes.
Pre-diabetes is the state that occurs when a person's blood glucose levels are impaired but this impairment does not qualify to be diagnosed as diabetes since they do not exhibit any of the clinical symptoms of this disease. Usually the pre-diabetic condition is induced by changes in body composition.
Impaired or an infirmity in body composition usually manifests as an increase in fat particularly central obesity. These accumulated fat cells act as hormone storehouses and start secreting cytokines that inhibit insulin sensitivity. This is the start of a condition called insulin resistance that is characterized by high circulating levels of blood glucose and insulin. This elevation in the levels of insulin and glucose in the blood leads to the conversion of glucose into fat storage causing a further increase in fat mass. This is the start of a vicious cycle, wherein fat mass keeps increasing leading to reduced lean muscle mass. Muscle mass is required for promoting glucose uptake. Hence, a reduction in lean muscle mass leads to reduced glucose uptake that further contributes to the already elevated glucose levels.
Elevated levels of circulating blood glucose are responsible for toxicity to the beta cells of the pancreas (“glucotoxicity”). In fact, beta cell dysfunction is initiated at the pre-diabetic stage. Additionally, by the time diabetes is diagnosed as per the criteria set forth by the World Health Organization or the American Diabetic Association, the pre-existing elevated blood glucose levels have already caused about 40-50% of beta cell dysfunction.
The combination of increased fat mass and the elevated blood sugar levels can be summarized as a series of cascading steps which is a cyclic process and starts with impaired body composition leading to increased fat and decreased lean muscle (skeletal) mass which goes on to cause a decreased glucose metabolism (pre-diabetes) and subsequently to the onset of Type 2 diabetes.

Hence, it can be concluded that reducing body fat is an imperative step in preventing/delaying the progression of pre-diabetes to a diabetic condition. Additionally a property of reducing blood glucose levels is an advantage in the management of pre-diabetes.
Additionally, studies have also indicated the role of body fat distribution in IGT ((Impaired Glucose Tolerance) and IFG (Impaired Fasting Glucose). Women with elevated blood glucose levels can be characterised by a higher accumulated, subcutaneous and total fat mass than women with normal blood glucose levels. Hence, the degree of adiposity, morphological and temporal distribution has all been found to be linked to the pre-diabetic condition. Since there is no single solution that addresses all the symptoms of Insulin Resistance or Pre-Diabetes, you must rely on a multi-faceted approach to reversing these conditions.
Currently, the pre-diabetic population is an unaddressed population, and there is a need for not only blood sugar management but also an improvement of body composition to prevent the progression of the condition and prevent other chronic conditions associated with high body fat content. Besides pre-diabetes there are many other conditions associated with an increased level of body fat (obesity) (Related conditions of increased body fat): insulin resistance, adult onset type 2 diabetes, heart disease and stroke, osteoarthritis, metabolic syndrome, polycystic ovary disease, etc.
Diabetes management requires a combination therapy of blood sugar management as well as an improvement in body composition. Additionally, the pre-diabetic population is increasing with the varied lifestyle choices and sedentary pattern that is setting in recent times.
Considering these factors, there is an unmet need for a therapeutically effective solution that is an answer to all these conditions.
Trigonella foenum graecum: 
Fenugreek (Trigonella foenum graecum) is one of the oldest medicinal plants and belongs to the family Fabaceae. This plant is widely grown in the Mediterranean regions, India, North Africa, Europe and China. Fenugreek is used both as herb and spice. Fenugreek seeds are very commonly used in India as a part of staple food grain. Fenugreek leaves are consumed widely in India as green leafy vegetables and are rich source of calcium, iron, beta-carotene and other vitamin. Fenugreek has a long history of therapeutic uses in Ayurvedic and Chinese medicine. Fenugreek has been reported to exhibit medicinal properties such as controlling the blood sugar, lipid lowering effect, reducing inflammation and controlling infection. This botanical is also thought to delay gastric emptying, slow carbohydrate absorption and inhibited glucose absorption.
The chemical composition of fenugreek seeds is Moisture—9%, Ash—3%, Lipids—8%, Protein—26% and Starch—6%. Additionally, fenugreek seeds also have a total fibre content of 48%, a gum content of 20% and a neutral detergent fibre content of 28%.
The therapeutic applications of fenugreek, namely, blood sugar lowering, slow absorption of glucose and carbohydrates, delayed gastric emptying and lipid and cholesterol lowering effects are attributed to the presence of gums in fenugreek seeds. Gums inherently have properties by which they can slow the absorption of molecules during the digestion and excretion process. They also play a role appetite suppression by delaying gastric emptying.
Typically, gums are either hydrophobic or hydrophilic high molecular weight molecules with colloidal properties that in an appropriate solvent or a swelling agent produce gels or highly viscous suspensions or solutions. The ability of gums to absorb appropriate solvents and swell is the main reason for the physiological effect of gum in the digestion process.
Seeds are an ancient source of gums. Most seeds contain starch as their principal food store that is used for the initial growth of the plant. Many seeds contain polysaccharide food reserves other than starch and some of these seeds are harvested to make dietary gums. These dietary polymers or gums are more commonly referred to as dietary fibres.
Gums or dietary fibres occur as linear chain compounds composed of sugar units which are called glycosyl units. Linear chains may have several hundreds of glycosyl units. Some dietary polysaccharides (fibres) occur as branched chain polysaccharides and are referred to as glycans. The molecular weights of both linear and branched chain fibres span a wide range of 2,000 Da-100,000 Da. An important difference between the linear and branched polysaccharides is their contribution to the viscosity of a solution. Linear fibres tend to render a solution more viscous than branched fibres. The viscosity increasing property of linear fibres is due to the mild hydrolytic cleavage of the linear molecule.
The main components which constitute the gum in the fenugreek seeds are galactose and mannose. These sugars link in specified proportions to form linear polysaccharide fibres. These polysaccharide sugars form the endosperm reserve. The gum or fibre obtained from fenugreek is known to be well suited for viscosity building and as a binding agent. Additionally, Fenugreek galactomannan is unique from other galactomannans due to the fact that the mannose galactose ratio is 1:1. In addition, it is more soluble in cold water than its existing counterparts are. Also, the documented evidence of fenugreek derived galactomannan gum or dietary fibre is approximately 30,000 Daltons. The yield obtained by the extraction of these galactomannans has been restricted to 15-20%.
Hence, the physiological functions of fibres are primarily due to their ability to swell in a specific solvent and to increase the viscosity of a given solution. These two properties contribute to delayed gastric emptying and lower levels of absorption of molecules in the presence of fibres.
Dietary fibres are composed of a large number of varying polysaccharides which are not metabolized in the upper digestive tract. Hence, when dietary fibre passes through the stomach into the small and then the large intestine, the swelling and rheology related properties of fibres contribute to their physiological function.
Due to their inherent bulking tendency, they add a significant amount of bulk to the contents as they pass through the gastrointestinal tract. Hence, they decrease the contact of the small and large intestine to the molecules that transit through them and thus lower the absorption of molecules like sugar. Additionally, they also surround the bile secreted in the small intestine and prevent its re-absorption, thereby lowering the availability of bile which is the starting point of cholesterol.
Also, their property to increase viscosity of a medium delays gastric emptying and hence causes appetite suppression.
Hence, it is concluded that these high molecular weight polysaccharides have a peripheral impact on the GIT health. Peripheral impact refers to a location specific action. This action is not systemic since it does not get absorbed into the blood stream. Absorption of these polysaccharides is not possible due to a high molecular weight. Hence, the action on these high molecular weight molecules is limited to the location of their presence.
Prior Art:
United States Patent Application 2008/0027024 refers to a combination of glucomannan, xanthan gum and alginate to produce viscosity so as to deliver a dietary fibre for the use of promoting satiety, promoting weight loss, lowering blood glucose levels, or lowering blood cholesterol levels in a mammal. This patent refers to a combination of different gums so as to achieve the desired viscosity to promote the functions claimed in the document.
US Patent Application 2007/0098763 refers to a composition that consists of glucomannan and at least one galactomannan. In this patent, the glucomannan referred to is derived from the roots or corm of the konjac plant. Also, these polysaccharides consist of glucose and mannose in the ration 5:8. A main point in the glucomannan derived from the konjac plant is that the molecular weight of this glucomannan is the highest of any known fibre and ranges from 200,000-2,000,000 Daltons. Since this is a high molecular weight fiber, it will not be absorbed into the blood stream will hence have only a peripheral action on the body of the subject.
U.S. Pat. No. 5,847,109, refers to a composition containing fenugreek derived galactomannans with at least 50 repeating units. The molecular weight of this claimed compound would be ˜18,000 Daltons. This is a high molecular weight compound. Since this is a high molecular weight compound, it will not get absorbed into the blood stream. The effect claimed in this patent related to reduction in post prandial glucose, cholesterol reduction and enhanced insulin response are related to the peripheral action of any dietary fiber. This action is location specific and is generated from the small and large intestines. Since these molecules are of large molecular weights and are gums, they enter the small intestine, absorb the water, swell up and occupy a large part of the lumen of the large intestine thereby preventing the absorption of sugars and the re-absorption of bile to produce cholesterol. This peripheral action of this composition is responsible for it physiological function. This composition cannot get absorbed into the blood stream due to its high molecular weight and hence will not produce a systemic action.
U.S. Pat. No. 7,141,254, relates to a composition for the treatment of diabetes which includes trigonelline, amino acids and galactomannan. Also, the galactomannan referred to in this patent is present in the range of 10-60%. Additionally, there is no data on the effect of galactomannan independent of trigonelline and amino acids.